On April 24, 2015, the newly purchased full-automatic biochemistry analyzer Roche Cobas C501 by the laboratory in our company passed “ 3Q Approval”.

As one part of quality system approval, “3Q Approval”is mostly common in the certification of precise instrument. Generally speaking, 3Q falls into three parts: IQ(installation qualification), OQ(operational qualification), and PQ (performance qualification). IQ, referred to as installation qualification,is to validate the instrument file, components and installation process. OQ, referred to as operational qualification,is to validate the normal functioning of instrument in idling conditions and operation limit range. PQ, referred to performance qualification, is to validate the instrument carrying samples to meet the prescribed standards in work condition.  The performance of the analyzer in laboratory has a direct impact on the accuracy and reliability of tested data, which will affect and restrict the improvement of enterprise’s standard of quality management.

The pass of “3Q Approval” in our company’s laboratory instrument and equipment has laid a valid foundation for experimental analysis to obtain high-quality data and been significant in guarantying accuracy and reliability of enterprise’s high-quality data.